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Listed below are the details for the data element.

1.14
Element Type
Common Data Element
Ethnicity USA category
EthnUSACat
Short Description
Category of ethnicity the participant/subject most closely identifies with
Definition
Category of ethnicity the participant/subject most closely identifies with
 

Biomedical Terminologies and Standards

Notes
cdRNS|eyeGene|FITBIR|NIA|PDBP; CDISC variables: DM=Demographics, SUPPDM= SUPPQUAL for Demographics, SC=Subject Characteristics, ETHNIC. For more information, refer to https://wiki.cdisc.org/pages/viewpage.action?pageId=32815150. Core CDEs from ONC SET OF DATA CLASSES TO SUPPORT NATIONWIDE INTEROPERABILITY
Creation Date
2014-04-01
Historical Notes
Ethnicity USA category
References
The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of Core racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307.

Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
Pre-Defined Values
Population
Adult and Pediatric
Guidelines/Instructions
Choose one. Response is obtained by report of the participant/subject or caretaker. If more detailed characterizations of ethnicity are collected to enhance data quality and consistency, it is recommended that they be "collapsible" up to the two categories for reportable ethnicity, as needed for reporting to FDA under its guidance. Other regulatory bodies may expect the reporting of ethnicity values which more appropriately reflect the population of their areas (e.g., Japanese ancestry for MHLW reporting to Japan). These may be collected as an extension to the suggested code list. The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm)
Preferred Question Text
What is the subject's ethnic background?
Category Groups and Classifications
DiseaseDomainSub-Domain
Amyotrophic Lateral Sclerosis Participant/Subject Characteristics Demographics
Spinal Muscular Atrophy Participant/Subject Characteristics Demographics
Headache Participant/Subject Characteristics Demographics
Multiple Sclerosis Participant/Subject Characteristics Demographics
Neuromuscular Diseases Participant/Subject Characteristics Demographics
Friedreich's Ataxia Participant/Subject Characteristics Demographics
General (For all diseases) Participant/Subject Characteristics Demographics
Traumatic Brain Injury Participant/Subject Characteristics Demographics
Epilepsy Participant/Subject Characteristics Demographics
Stroke Participant/Subject Characteristics Demographics
Huntington's Disease Participant/Subject Characteristics Demographics
Myasthenia Gravis Participant/Subject Characteristics Demographics
Parkinson's Disease Participant/Subject Characteristics Demographics

Classification

Stroke :
Core
Huntington's Disease :
Core
Moderate/Severe TBI: Rehabilitation :
Core
Epidemiology :
Core
Multiple Sclerosis :
Core
Epilepsy :
Core
Myasthenia Gravis :
Core
General (For all diseases) :
Core
Headache :
Core
Acute Hospitalized :
Core
Amyotrophic Lateral Sclerosis :
Core
Spinal Muscular Atrophy :
Core
Concussion/Mild TBI :
Core
Friedreich's Ataxia :
Core
Parkinson's Disease :
Core
Neuromuscular Diseases :
Core
Keywords
COVID19
Labels
NINDS_CDE
Effective Date
Until Date
Last Change Date
2023-08-11
See Also
Submitting Organization Name
NIH/NINDS
Submitting Contact Name
NINDSCDE
Submitting Contact Information
NINDSCDE@emmes.com
Steward Organization Name
NIH/NINDS
Steward Contact Name
NINDSCDE
Steward Contact Information
NINDSCDE@emmes.com
NINDS ID

Change History